Montefiore Health System and Albert Einstein College of Medicine in the Bronx, New York, are the first sites in the nation to begin evaluating an investigational drug in two separate, FDA-approved clinical trials: one to treat mild-to-moderate cases of COVID-19, and the other to treat severely ill COVID-19 patients. The sites are hopeful that the drug, leronlimab, may prevent the “cytokine storm” that inflames and fatally damages the lungs and other organs of many COVID-19 patients. Harish Seethamraju (photo), MD, an organ transplant specialist and a member of the Department of Medicine at Montefiore and Einstein, researched leronlimab early in the pandemic and realized its potential for treating his transplant patients who had COVID-19. He then obtained “compassionate use” permission from the Food and Drug Administration (FDA) so that he and his colleagues could use leronlimab on 10 severely ill COVID-19 patients, six of them transplant patients from various organ transplant programs. “By calming the overactive immune systems of these patients, leronlimab halted the inflammation and blood clotting that are so damaging to the lungs, liver, and kidneys of severely ill COVID-19 patients,” said Dr. Seethamraju. All 10 patients had extremely high blood levels of CCL5 (also known as RANTES), which is an inflammatory molecules known as a cytokine. This is why the extreme inflammatory response is known as the “cytokine storm.” Leronlimab interfered with those CCL5/RANTES molecules, preventing them from directing immune cells to swarm into and inflame the lungs and other organs.
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